Potency of botulinum toxin drugs: test systems and labelling

Cell-based assays are a novel method to determine potency of botulinum toxin drugs. Manufacturers are working on their acquisition, development and implementation to reduce animal consumption during the manufacturing process. Potency labelling of botulinum toxin drugs differes principally between Ipsen and the other manufacturers. Reference to a uniform international standard would avoid this potentially dangerous situation. However, this has not been demanded by the registration authorities and has not been persued by the manufacturers for decades.